drugset / Trial / NCT00796081
A Safety and Pharmacokinetic Study of ER OROS Paliperidone in Pediatric Patients With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
RandomizedSingle-groupOpen-labelTreatment
Summary
The purposes of this study are to characterize the pharmacokinetics of paliperidone after single- and multiple-dose administration of paliperidone ER in children and adolescent patients (\>= 10 to \<= 17 years of age) with schizophrenia, schizoaffective disorder, or schizophreniform disorder and to evaluate the safety and tolerability of paliperidone ER in this patient population.
Timeline
- Start
- 2006-01
- Primary completion
- —
- Completion
- 2006-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paliperidone | Unknown | 0.086 mg/kg | Oral |
| Subject | Paliperidone | Unknown | 0.129 mg/kg | Oral |
| Subject | Paliperidone | Unknown | 0.171 mg/kg | Oral |